FDA顾问团称：总体而言对Enbrel的Ae报告比Remic
GAITHERSBURG, MD (Reuters Health) - The US Food and Drug Administration's (FDA's) Arthritis Drugs Advisory Committee heard updated postmarketing adverse event data on Friday for two rival rheumatoid arthritis (RA) drugs, Centocor's Remicade (infliximab) and Immunex's Enbrel (etanercept).
Overall, there have been more reported events concerning Enbrel than Remicade, the panel was informed. But Immunex maintained that the higher number of reports could be a product of its efficient collection system rather than its drug's safety profile.
In addition, while the number of reports was higher for Enbrel, Remicade has been more closely associated with certain serious infections, including tuberculosis. Centocor said earlier this week that it would add a black box warning to Remicade concerning TB and other infections; Enbrel does not carry a boxed warning and Immunex has said that it does not expect it will need to add one.
Remicade was approved in October 1998 for Crohn's disease and November 1999 for RA. Enbrel was approved in November 1998 for RA. The FDA panel appeared in agreement on Friday that, despite the necessity for caution in using the drugs, their benefits continue to outweigh their risks.
The FDA has received 2,300 adverse event reports on Remicade, which has been taken by an estimated 147,000 patients worldwide. Twenty-six percent of those reports were related to infections.
There have been 18,500 reports on Enbrel, 22% of them infection-related, with 102,000 patients worldwide receiving the drug since it was approved. Recent reports suggest that Enbrel may be contributing to higher lymphoma rates, but Immunex said the incidence still seems to be much lower than might have been expected.
Both Remicade and Enbrel inhibit tumor necrosis factor-alpha, which regulates inflammation. But they have slightly different chemical properties and actions. Remicade is a chimeric mouse-human monoclonal antibody, while Enbrel fuses several human proteins., 百拇医药
Overall, there have been more reported events concerning Enbrel than Remicade, the panel was informed. But Immunex maintained that the higher number of reports could be a product of its efficient collection system rather than its drug's safety profile.
In addition, while the number of reports was higher for Enbrel, Remicade has been more closely associated with certain serious infections, including tuberculosis. Centocor said earlier this week that it would add a black box warning to Remicade concerning TB and other infections; Enbrel does not carry a boxed warning and Immunex has said that it does not expect it will need to add one.
Remicade was approved in October 1998 for Crohn's disease and November 1999 for RA. Enbrel was approved in November 1998 for RA. The FDA panel appeared in agreement on Friday that, despite the necessity for caution in using the drugs, their benefits continue to outweigh their risks.
The FDA has received 2,300 adverse event reports on Remicade, which has been taken by an estimated 147,000 patients worldwide. Twenty-six percent of those reports were related to infections.
There have been 18,500 reports on Enbrel, 22% of them infection-related, with 102,000 patients worldwide receiving the drug since it was approved. Recent reports suggest that Enbrel may be contributing to higher lymphoma rates, but Immunex said the incidence still seems to be much lower than might have been expected.
Both Remicade and Enbrel inhibit tumor necrosis factor-alpha, which regulates inflammation. But they have slightly different chemical properties and actions. Remicade is a chimeric mouse-human monoclonal antibody, while Enbrel fuses several human proteins., 百拇医药